Grants Manual - Section on: Proposal submission and evaluation - Europa EU
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EUROPEAN COMMISSION Directorate-General for Research & Innovation Grants Manual - Section on: Proposal submission and evaluation (sections III.5, III.6, IV.1, IV.2) Version 1.4 28 May 2015
History of changes Version Date Changes 1.1 23.05.2014 New annotations regarding hyperlinks and references Updated chapters on “Ethics review” and “Security scrutiny” 1.2 15.01.2015 Complaints point was added to Submit a proposal section 1.3 22.04.2015 Table of content updated 1.4 28.05.2015 The response deadline to complaints about failed submission is specified in the AoR
H2020 Grants Manual: May 2015 Table of content I. Introduction II. H2020 grants: background and principles II.1 Principles governing the award of grants II.2 H2020 types of grants and funding rates III. Applying for funding III.1 Find a call III.2 Find partners III.3 Get a user account in the electronic exchange system III.4 Register in the Beneficiary Register III.5 Submit a proposal .................................................................................................................. 4 III.6 Admissibility & Eligibility check .......................................................................................... 8 IV. From evaluation to grant signature ...................................................................................... 10 IV.1 Evaluation of proposals and operational capacity check .................................................... 10 IV.2 Grant preparation ................................................................................................................. 18 IV.2.1 Ethics review (ethics screening and ethics assessment) ............................................... 18 IV.2.2 Security scrutiny ........................................................................................................... 21 IV.2.3 Legal entity validation IV.2.4 Financial capacity check IV.2.5 Non-exclusion check IV.2.6 Grant award letter IV.3 Grant signature V. Managing your grant V.1 Keeping records V.2 Certifications V.3 Reports and payment requests V.4 Deliverables V.5 Dissemination of results - patents and publications V.6 Amendments V.7 Checks, audits, reviews and investigations 3
H2020 Grants Manual: May 2015 Differences to FP7 III.5 Submit a proposal recommendations of experts limited ‘negotiation’ replaced by ‘grant preparation’ Summary This section explains: how you can submit a proposal Key points We will treat your proposal confidentially, as well as any related information, data, and documents we receive from you. We will ensure that the process of handling and evaluating proposals is carried out in a confidential manner. External experts are also bound by an obligation of confidentiality. You too should avoid taking any actions that could jeopardise confidentiality. You must not attempt to discuss your proposal with persons you believe may act as expert evaluator for the Commission/Agency. Your proposal is archived under secure conditions at all times. After the evaluation and signature of any subsequent grant agreement, all copies are destroyed except those required for archiving or auditing purposes. Your proposal should not contain any information that is ‘EU classified’ under the rules on security of information in the Commission internal Rules of Procedure (see also Guide for classification). We will process personal data in accordance with Regulation No 45/2001 and according to the ‘notifications of the processing operations’ to the Data Protection Officer (DPO) of the Commission/Agency (publicly accessible in the DPO register). Once the coordinator (or sole applicant) has submitted a proposal, you will not hear from us until the proposal has been evaluated, unless: o we need to contact you (usually through the coordinator) to clarify matters such as eligibility or to request additional information o we need more information, or supporting documents, for legal entity validation, financial viability check, ethics review or security scrutiny o you have made an enquiry or a complaint or o the evaluation process involves hearings. For details on your call see the call topic information. There is a Helpdesk available to deal with issues relating to the electronic submission of proposals. For information on how to register concerns or enquiries please look on the Participant Portal. To contact us please use only the electronic exchange system (i.e. the ‘My Area’ section of the Participant Portal). 4
H2020 Grants Manual: May 2015 1. Before proposal submission 1.1 Draft proposals The coordinator can enter draft proposals in the ‘Electronic Submission Service’ of the Participant Portal (accessible via the topic page of your call), using the forms and templates provided there. For tips on the ethics self-assessment, see How to complete your ethics self-assessment. 1.2 Mock evaluation As part of the topic information for your call, you will find a link to the evaluation forms similar to those used by our experts for the evaluation of your proposal. It is strongly recommended that you use these forms to assess the strengths and weaknesses of your proposal before you submit it. Ideally, ask a disinterested colleague to carry out a mock evaluation. 1.3 Checklist for submission Before the coordinator (or sole applicant) officially submits the proposal, check that: your proposal fulfils the conditions set out in the call the proposal (both the administrative forms and technical annex) is complete, readable, accessible and printable the requested declarations have been made all consortium members have: obtained access to the electronic exchange system (i.e. the ‘My Area’ section of the Participant Portal) (see section III.3) registered in the Beneficiary Register. Specific schemes: Rules: two-stage submission schemes Art 15 RfP continuous submission schemes WP/call multi-step evaluation schemes 2. Submitting your proposal Proposals must be submitted by the coordinator on-line via the Electronic Submission Service of the Participant Portal and before the call deadline. Specific cases: For two-stage submission schemes, you must submit a ‘short outline proposal’ for the first stage and you will be invited to submit your ‘full proposal’ for the second stage, if you pass the first-stage evaluation. The full proposal must be consistent with the short outline proposal and may not differ substantially. Some calls may be continuously open for submission at any time. In these cases, the call will set intermediate or final closure dates and specify whether: the evaluation of proposals will be carried out within one month of that date proposals will be evaluated individually as they arrive and ranked after the next intermediate or final closure date. 5
H2020 Grants Manual: May 2015 If you miss an intermediate closure date, the proposal will be evaluated in the next evaluation session. We will record the date and time the coordinator submits the proposal, and immediately send a confirmation e-mail to all applicants. If you have not received this e-mail, it is because the proposal has not been submitted. If you miss the call deadline, your proposal will be disregarded by the system and we will not consider it as submitted. The system carries out basic verification checks for completeness of the proposal, internal data consistency, virus infection file types, size limitations etc. The system will check page limits in specific parts of the proposal and, if necessary, suggest that you shorten it. After the deadline, unless otherwise indicated in the call, any excess pages will be overprinted with a ‘watermark’, indicating to evaluators that these pages must be disregarded. Before the call deadline, the coordinator may replace the proposal with new proposals. We will only keep for evaluation the most recent version submitted. After the call deadline, changes or additions are no longer possible, unless we ask you to clarify any obvious clerical errors on your part. After the call deadline (or intermediate or final closure date for continuous submission schemes), the system will issue an e-receipt which will be available to all participants via the Participant Portal; it will contain the full proposal incl. proposal title, acronym and unique proposal identifier (proposal number) the name of the relevant programme part and call identifier and the date and time of receipt (i.e. the call deadline). If during the final days of the submission process there is a fault in the system, we may decide to extend the call deadline accordingly. 3. After proposal submission 3.1 Access by the Commission/Agency We have no access to the proposal before the call deadline. However, so that we can plan the evaluation process and meet the deadline for informing you of the outcome, we will ask you consent to access certain information before the call deadline: the call title and the topic for which the proposal is submitted the title of the proposal, summary information, keywords the identity codes of your organisation(s) for Marie Skłodowska-Curie actions: the relevant panel. 6
H2020 Grants Manual: May 2015 A disclaimer will inform you that we will be accessing this information and we will give you the opportunity to refuse access. Some calls allowing for continuous submission may indicate that proposals will be evaluated individually as they arrive. They will be ranked after the closure date specified in the call. In those cases, we may access your proposal from the moment of submission. 3.2 Withdrawing a proposal The coordinator can subsequently withdraw your proposal – the guidance documents will explain how to do this. 3.3 Multiple proposals If the coordinator submits a number of similar proposals, we may ask him to choose one or more of them to be withdrawn. 3.4 Complaints If you think that the submission of your proposal was not entirely successful due to a technical error on the side of the Commission, the coordinator may lodge a complaint through the IT Helpdesk on the Participant Portal. For the complaint to be admissible it must be filed within 4 calendar days following that of the call closure. You will receive an acknowledgement of receipt the same or next working day. You should secure a PDF version of all the B-parts and annexes of your proposal holding a time stamp (file attributes listing the date and time of creation and last modification) that is prior to the call deadline dd/mm/yyyy:hh:mm , as well as any proof of the alleged failure (e.g. screen shots). Later in the procedure you may be requested by the IT Helpdesk to provide these items. Please, note that any information regarding the proposal will be treated in a strictly confidential manner. In order that a complaint would be upheld, the IT audit trail (application log files and access log files of the EC IT-systems involved) must show that there was indeed a technical problem at the EC side which prevented you from submitting (or resubmitting) the proposal using the electronic submission system. You will be notified about the outcome of the treatment of your complaint as soon as possible and at latest within the time indicated in the acknowledgment of receipt (AoR). If a decision cannot be reached in this term you will receive a holding reply. If your complaint is upheld, the secured files (provided by you to the IT helpdesk), for which the investigation has demonstrated that technical problems at the EC side prevented (re)submitting, will be used as a reference for accepting the proposal for subsequent evaluation. In absence of such documents, the version present in the IT system will be evaluated. 7
H2020 Grants Manual: May 2015 Rules: III.6 Admissibility & Eligibility check Art 131(2) FR Art 201 RAP Art 7-10 RfP Summary WP/call This section explains how and why the Commission/Agency: checks admissibility and eligibility of the proposal 1. Admissibility & eligibility check We will check your proposal for inadmissibility (against the standard admissibility conditions set out in General Annex B to the Main Work Programme and, if relevant, the specific conditions on admissibility set out in the work programme for your call). To be considered admissible, a proposal must be: submitted in the Electronic Submission System before the deadline given in the call conditions readable, accessible and printable. Incomplete proposals may be considered inadmissible. This includes the requested administrative data, the proposal description, and any supporting documents specified in the call. General Annex B to the Main Work Programme lists the necessary supporting documents. In case of an ‘obvious clerical error’ (e.g. omission to submit evidence or information on a non- substantial element of the proposal), we may first ask you to provide the missing information or supporting documents. If the missing information or document would substantially change the proposal, it will not be taken into account. We will also check your proposal for ineligibility (against the standard eligibility criteria set out in General Annexes A and C to the Main Work Programme and the specific eligibility conditions set out in the work programme for your call). Example: Research & innovation actions (RIA) require, for instance, a minimum of three independent legal entities established in different Member States or associated countries1. Your proposal must also correspond to the topic description for your call. For more information on participation of third country participants, see section on cross- cutting issues (international cooperation). Specific cases: In the case of two-stage submission schemes, an eligibility check is carried out at first stage. At second stage, we will check that the eligibility conditions are still complied with. If your Marie Skłodowska-Curie action proposal is ineligible for call you submitted it for, but eligible in another open call, we will transfer to that call. 1 Further conditions may be set out in the work programme. 8
H2020 Grants Manual: May 2015 2. Outcome of the admissibility & eligibility check If your proposal is considered inadmissible or ineligible, we will inform your coordinator (via a ‘proposal rejection letter’ sent through the electronic exchange system), together with the reasons why and how to appeal. If the proposal is (for the moment) eligible, but you are not, we will inform you and your coordinator (via an ‘applicant rejection letter’ sent through the electronic exchange system). 9
H2020 Grants Manual: May 2015 IV From evaluation to grant signature Rules: Art 128(2), 131(3), 132(1,2), 133 IV.1 Evaluation of proposals and operational FR capacity check Art 202, 203, 204 RAP Art 15, 40 RfP WP/call Summary This section explains how the Commission/Agency chooses its experts evaluates your operational capacity evaluates your proposal (on its scientific merit) establishes its ranked list Key points We will evaluate your proposal with the help of independent external experts. We will be guided by the following: o Excellence Proposals must demonstrate high quality in relation to the topics and criteria set out in the calls. o Transparency Funding decisions must be based on clearly described rules and procedures, and applicants should receive adequate feedback on the outcome of the evaluation. o Fairness and impartiality All proposals submitted in response to a call are treated equally and evaluated impartially on their merits, irrespective of their origin or the identity of the applicants. o Efficiency and speed Evaluation, award and grant preparation should be done as quickly as possible without compromising quality or neglecting the rules. o Ethics and security Proposals must not contravene fundamental ethical principles or relevant security procedures. 1. Evaluation and operational capacity If your proposal is admissible and eligible (or if admissibility and/or eligibility cannot immediately be determined), it will be evaluated by independent experts on its scientific merits. All proposals within a call (or within a coherent part of a call) are evaluated together. Specific cases: For two-stage submission schemes, there is a first-stage and a second-stage evaluation (against the evaluation criteria for each stage). In a two-stage submission scheme, proposals must pass all thresholds to pass to the second stage. For continuous submission schemes, there is normally an evaluation session after the intermediate or final closure dates (normally within a month). The work programme/call may provide for evaluation when the proposals arrive. In this case they are all ranked after the intermediate or final closure date and evaluation results are made available immediately. If the work programme/call provides for a combination of continuous submission scheme and two- stage submission scheme, the first-stage short outline proposals may be evaluated on a continuous basis when they are received and the full proposal will be evaluated after the intermediate closure date for the second-stage evaluation. 10
H2020 Grants Manual: May 2015 For ‘multi-step evaluations’, different experts may be examining the different criteria. Proposals failing a threshold score may not progress to the next step. To evaluate your capability, the experts will also give an opinion on your operational capacity to implement the action. 2. Evaluation by independent experts In order to ensure that only proposals of the highest quality are selected for funding, we rely on independent experts for the evaluation of proposals (‘evaluators’). How are the evaluators selected? We appoint independent evaluators for each call from the database of experts. When selecting evaluators, we look for: a high level of skill, experience and knowledge in the relevant areas (e.g. project management, innovation, exploitation, dissemination and communication) and, provided the above condition can be satisfied, a balance in terms of: skills, experience and knowledge geographical diversity gender where appropriate, the private and public sectors, and an appropriate turnover from year to year. In principle, your proposal will be examined initially by at least three experts (in many cases, five or more). Specific case: For the first stage in two-stage submission schemes and for low-value grants, it may be that only two experts are used. Additional ethics experts will be appointed for the ethics review. In addition, the evaluation process may be followed by one or more independent observers: to observe the practical workings of the evaluation process to give independent advice on: the conduct and fairness of the evaluation sessions the application of the award criteria ways in which the procedures could be improved but not to express views on the proposals or the other experts’ opinions. 11
H2020 Grants Manual: May 2015 Experts that have a conflict of interests will be excluded by us. We consider that a conflict of interest exists, if an expert: was involved in the preparation of a proposal benefits directly or indirectly if a proposal is accepted has a close family or personal relationship with any person representing an applicant is a director, trustee or partner or is in any way involved in the management of an applicant is employed or contracted by one of the applicants or any named subcontractors Such an expert may, however, exceptionally be invited to take part in the evaluation session, if all of the following apply: the expert works in a different department/laboratory/institute from where the action is to be carried out the bodies operate with a high degree of autonomy and such a role is justified by the requirement to appoint the best available experts and by the limited size of the pool of qualified experts (and this is documented). is a member of an advisory group (set up by the Commission to advise on the preparation of EU or Euratom Horizon 2020 work programmes) in an area related to the call is a National Contact Point (NCPs) or persons directly working for the Enterprise Europe Network (EEN) is a member of a programme committee We will decide whether a conflict of interest exists — taking account of the objective circumstances, available information and related risks — when an expert: was employed by one of the applicants in the last three years is involved in a contract or grant agreement, grant decision, membership of management structures (e.g. member of management or advisory board etc.) or research collaboration with an applicant or a fellow (or had been so in the last three years) is in any other situation that could cast doubt on their ability to participate in the evaluation of the proposal impartially (or that could reasonably appear to do so in the eyes of an external third party). We will publish on the “Reference Documents” page of the Participant Portal at least once a year the list of experts who have assisted us together with their area of expertise. 12
H2020 Grants Manual: May 2015 3. Award criteria — Scoring — Thresholds Your proposal will be evaluated against the following award criteria: excellence, impact and quality and efficiency of implementation and according to the weighting and thresholds that are set out in the work programme (General Annex H to the Main Work Programme). In order to be considered for funding, your proposal must score above a certain threshold for each criterion, and above an overall threshold. Thresholds may vary according to the work programme. Specific case: For two-stage submission schemes, thresholds and the maximum overall score may vary between the first and the second stage. For each criterion, your proposal will be given scores of 0 to 5 (half marks are possible), as follows: 0— The proposal fails to address the criterion or cannot be assessed due to missing or incomplete information (unless the result of an ‘obvious clerical error’) 1— Poor: the criterion is inadequately addressed or there are serious inherent weaknesses 2— Fair: the proposal broadly addresses the criterion but there are significant weaknesses 3— Good: the proposal addresses the criterion well but with a number of shortcomings 4— Very good: the proposal addresses the criterion very well but with a small number of shortcomings 5— Excellent: the proposal successfully addresses all relevant aspects of the criterion; any shortcomings are minor. The maximum overall score is therefore 15. Exception: For the Marie Skłodowska-Curie (MSC) actions and SME instrument, scores with a resolution of one decimal place may be awarded. If the work programme/call provides for a weighting factor, this will be used to determine the final ranking. Proposals will be evaluated on their own merit, and not their potential should certain changes be made. Proposals with an inflated budget are likely to receive a lower score. 13
H2020 Grants Manual: May 2015 4. Evaluation process The evaluation process has three phases: Phase 1 — Individual evaluation Phase 2 — Consensus group Phase 3 — Panel review Before starting the evaluation process, the experts are briefed on: the evaluation processes and procedures (including selection and award criteria) the content of the R&I topics under consideration the terms of their contract (e.g. confidentiality, impartiality, conflicts of interest, completing tasks and approving reports, penalties for non-compliance) disregarding excess pages the need to evaluate proposals as they were submitted, rather than their potential should certain changes be made. In Horizon 2020, there will no scope for recommending improvements to proposals (including improvements on the budget). In particular, proposals with a significantly inflated budget, taking into account cost efficiency considerations, will receive a lower score and may not pass the threshold. 4.1 Phase 1 — Individual evaluation Each expert carries out an evaluation and prepares an ‘individual evaluation report (IER)’ with comments and scores for each criterion. They also indicate if the proposal: falls entirely outside the scope of the part of the call which they are evaluating or involves security issues that will need further scrutiny. 4.2 Phase 2 — Consensus group The individual experts then form a ‘consensus group’ to come to a common view and agree on comments and scores (in a ‘consensus report’). Specific cases: If foreseen in the work programme/call, an arithmetic average (i.e. median or mean value) of the individual scores may be taken as the consensus score (e.g. for the first stage of two-stage submission schemes, SME Instrument actions). The ‘mean’ is the total score of the experts, divided by the number of experts. The ‘median’ is found by arranging all the scores from lowest value to highest value and picking the middle one (e.g. the median of {3, 5, 9} is 5). If there is an even number of experts, then there is no single middle value; the median is then the mean of the two middle scores (e.g. the median of {3, 5, 7, 9} is (5 + 7) / 2 = 6). 14
H2020 Grants Manual: May 2015 If foreseen in the work programme/call the consensus report may consist in a collation of the individual evaluation reports or extracts from them (e.g. the first stage of two-stage submission schemes; SME Instrument actions) If you have submitted your proposal to the Commission/Agency previously under Horizon 2020 or any other programme in the past two years, and if the work programme topics and criteria were comparable, the moderator of the consensus group may give a copy of the previous Evaluation Summary Report (see below) to the experts. The group has an impartial ‘moderator’ (normally a Commission/Agency staff member), who: seeks a consensus and ensures that proposals are evaluated fairly, in line with the criteria. If a consensus group cannot reach a common view, the consensus report will set out both the majority view and the dissenting views. In some cases we may ask additional experts to examine the proposal, to establish whether a clear majority view exists. 4.3 Phase 3 — Panel review Finally, a panel will review all the proposals within a call, or part of a call, to: make sure that the consensus groups have been consistent in their evaluations if necessary, propose a new set of marks or comments and resolve cases where a minority view was recorded in the consensus report. There will be no panel review: the evaluation concerns stage 1 proposals in a two-stage submission schemes the Work Programme/call provides for an exception if there are sufficient funds to support all the proposals that passed the relevant thresholds. Specific case: There will also be no separate panel review if the same consensus group has examined all the proposals. In this case their final review will be done together with the consensus reports. This is considered to constitute the panel review. The panel review is guided by a ‘panel chairperson’ (normally a Commission/Agency staff member) who must ensure fair and equal treatment of the proposals. A rapporteur (who may also be the chair) may be appointed to draft the panel report. As part of the panel deliberations, the Commission/Agency may organise hearings with the applicants to: clarify the proposals and help the panel establish their final assessment and scores or improve the experts’ understanding of the proposal. The call documents will indicate if hearings will be organised. 15
H2020 Grants Manual: May 2015 Invitations to hearings are sent only to the coordinators of proposals with consensus scores above the individual and overall thresholds and, in some cases, also to those whose proposals passed the individual thresholds, but fell short of the overall threshold. Hearings may not be used to modify proposals. You may only provide explanations and clarifications in response to questions submitted to you in advance. You may choose not to attend the hearing and to reply only in writing. The panel may invite additional experts to clarify particular issues requiring specific expertise. These experts may not take position on the proposal as a whole. Hearings are usually held in Brussels, but may also be conducted by a written procedure, via telephone, or by video-conference. The ‘panel report’ includes the ‘evaluation summary report (ESR)’ for each proposal (based on the consensus report, including comments and scores, and taking into account the panel’s deliberations and any new scores or comments considered necessary), with explanations and a list of proposals passing all thresholds, along with a final score, (‘panel ranked list’) and, where necessary, the panel’s recommendations for a priority order for proposals in the event of equal scores, using the procedure set out in the work programme. You will receive a copy of your evaluation summary report, when you will be informed of the outcome of the evaluation by the experts. Exception: For two-stage submission schemes, the ESR of the first stage will not be sent to successful first stage applicants, unless this is provided for in the Work Programme/call. (In such schemes, successful applicants will receive the grant information letter and ESR at the end of the second/last stage; at the end of the first stage, they will only be informed about the outcome and, if applicable, be invited to submit their full proposal.) 5. Outcome of the evaluation: Commission/Agency ranked list — Operational capacity check We will rank the proposals that passed the thresholds according to the results of the evaluation by the experts (‘Commission/Agency ranked list’). This ranked list consists of: a main list (proposals proposed for funding) normally also a reserve list (in case proposals are withdrawn, excluded or extra funding becomes available) a list of proposals that cannot be funded because of insufficient budget. In addition, we will make a list of proposals that didn’t pass the thresholds or has been found to be ineligible (e.g. out of scope). 16
H2020 Grants Manual: May 2015 If — on the basis of this ranking and the available budget — your proposal is on the main list, we will invite you to the grant preparation stage (via a ‘grant information letter’ sent through the electronic exchange system). Specific case: For two-stage submission schemes, if you successfully pass the first stage, you will receive the information letter at the end of the second stage; at the end of the first stage, you will be informed that your short outline proposal has been successfully evaluated and only be invited to submit your full proposal. This is not a commitment that we will fund your project. You will receive this letter within 5 months of the call deadline. If your proposal is put on a reserve list, we will inform your coordinator and let him/her know of any subsequent change. If your proposal has not been retained for funding, we will inform your coordinator (via a ‘proposal rejection letter’ sent through the electronic exchange system), together with the reasons why and how to appeal. If the proposal is retained for funding, but you may not participate (e.g. because you are found to have insufficient operational capacity or to be ineligible), we will inform you and your coordinator (via an ‘applicant rejection letter’ sent through the electronic exchange system). 17
H2020 Grants Manual: May 2015 IV.2 Grant preparation Rules: IV.2.1 Ethics review (ethics screening and ethics assessment) Art 19 H2020 FP Reg Art 13(2,3), 14 RfP Summary This section explains how and why the Commission/Agency makes an ethics review. Key points During proposal submission, you are asked to fill out the ‘ethics self-assessment’ for your proposal. This consists of: the ‘ethics issue table’ in Part A of the proposal templates and ‘ethics self-assesment’ in Part B of the proposal templates (i.e. a description of how the identified ethics issue is addressed and how it complies with applicable laws. We will check if your proposal complies with ethical principles (including research integrity) and applicable international, EU and national law. All proposals will be screened for ethics issues (‘ethics screening’). Proposals raising serious or complex ethics issues must undergo an ‘ethics assessment’ (e.g. proposals involving the use of human embryonic stems cells (hESCs); significant research integrity issues). Proposals that contravene ethical principles may be excluded at any time. 1. Ethics review In parallel to the evaluation (or soon after), we will check — with the help of independent ethics experts — if your proposal complies with ethical principles and relevant legislation. 2. Ethics issues Although the main focus is on the ethical dimension (e.g. human rights and protection of human beings, animal protection and welfare, data protection and privacy, environmental protection, malevolent use of research results), we will also look at ‘research integrity’ issues (e.g. fabrication, falsification or plagiarism, including misrepresenting credentials and authorship improprieties). 18
H2020 Grants Manual: May 2015 3. Ethics review process The ethics review process has one or two stages: Stage 1 — Ethics screening Stage 2 — Ethics assessment All proposals will go through an ethics review process (made up of one or two consecutive steps, depending on whether or not ethics issues are confirmed, whether they are adequately addressed as well as their severity and complexity). We will start the ethics screening by flagging any ethics issues that are not already indicated in the ethics self-assessment of your proposal and then examine whether they are adequately handled. Exception: Proposals involving the use of human embryonic stems cells (hESCs) must always undergo an ethics assessment (without ethics screening). Example (ethics issues): impact on human beings, environment or animal welfare; processing of personal data; fabrication and falsification of date (plagiarism). If your proposal raises serious or complex ethics issues, it will have to also undergo an ethics assessment (i.e. a more in-depth analysis). Example (serious ethics issues that require ethics assessment): severe intervention on humans; multiple and interconnected ethics issues; lack of appropriate ethics framework in the country where the research will be conducted, etc. We may contact you during the ethics review, if we need more information or supporting documents. 4. Outcome of the ethics review: Ethics opinion The ethics review culminates in one or more ethics reports (one for the ethics screening and one for the ethics assessment, if necessary) with an ethics opinion. These ethics reports may: grant ethics clearance (for proposals that are ‘ethics-ready’, i.e. respect ethical principles and applicable law) grant conditional ethics clearance (for proposals where the experts make the clearance subject to conditions (i.e. ‘ethics requirements’) to be fulfilled before the signature of the grant agreement or to be included in the grant agreement) The conditions may include: regular reporting appointing an independent ethics advisor or board (that may notably be tasked to report to the Commission/Agency on the compliance with the ethics requirements) 19
H2020 Grants Manual: May 2015 an ethics check or audit submission of further information/documents necessary adaptation of the methodology to comply with ethical principles and relevant legislation recommend an ethics assessment, or refuse ethics clearance. The reports may also contain ethics recommendations. During an ethics assessment, the experts may request a second ethics assessment, if they consider that the elements submitted do not allow them to provide an opinion. If the report is positive (clearance or conditional clearance) or recommends an ethics assessment, it will be sent to your coordinator (via the electronic exchange system). If the report is negative (no ethics clearance), we will inform your coordinator (via a ‘proposal rejection letter’ sent through the electronic exchange system), together with the reasons why and how to appeal. 20
H2020 Grants Manual: May 2015 IV.2.2 Security scrutiny Summary This section explains how and why the Commission/Agency makes a: security scrutiny Key points If your project deals with information that is ‘EU-classified’ under the Commission internal Rules of Procedure, we will check how you propose to deal with information (see General Annex J to the Main Work Programme). For more information on ‘EU classification’, see the Guide for classification. The security scrutiny is not a fully-fleged security check on all potentially security- relevant aspects of a proposal; it is limited to identifying actions that involve security- sensitive information (and classifying them and their deliverables as ‘classified deliverables’). The security scrutiny does not concern other issues or ‘activities involving dual-use goods or dangerous materials and substances’. Security scrutiny will be used for most parts of Societal Challenge 7 — Secure Societies calls, but it may also apply to other proposals. 1. Security scrutiny If your proposal deals with information that is ‘EU-classified’ under the Commission internal Rules of Procedure2, it will have to undergo security scrutiny. 2. Proposals subject to security scrutiny Your project will be subject to security scrutiny if: you apply for funding under the Societal Challenge 7 — Secure Societies and your proposal falls under areas described in the Guide for classification you declare in the proposal that it is ‘security-sensitive’, i.e. concerns EU-classified information the topic is flagged in the Work Programme as potentially resulting in security-sensitive projects the Commission/Agency detects or suspects that: classified information is, or may be, used as background and/or it is planned that some results will be classified. 2 Commission Decision 2001/844/EC, ECSC, Euratom amending the Commission’s internal Rules of Procedure (OJ L 317, 3.12.2001, p. 1–55). Available at http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX:02001D0844-20050202&qid=1395937087333&from=EN. 21
H2020 Grants Manual: May 2015 3. Documents and information to be provided Unless you have already included them in your proposal, we will contact you to request the following: a ‘Security Aspect Letter (SAL)’ and ‘Security Classification Guide (SCG) 3’, covering the level of classification of background information (and the formal written authorisation by the competent security authorities to use this information); the classified results (including which participant will have access to what information). a copy of the ‘Facility Security Clearances (FSC)’ (or of the FSC request). The validity of the FSC may be checked by the Commission Security Directorate through the appropriate formal channel with the national security authorities (NSAs) involved. 4. Security scrutiny process The ‘security scrutiny committee’ will check: the level of sensitivity of your proposal and that you have properly addressed all the security aspects. This committee will give a recommendation on the level of ‘EU classification’ that is necessary. If classification is required, the Security Aspect Letter (SAL)’ and ‘Security Classification Guide (SCG)’ will become ‘security requirements’ in Annex 1 to the grant agreement. It will be EU-classified at the level of the highest classification of the information used/produced by the action as indicated in the ‘security aspects letter (SAL)’ and ‘security classification guide (SCG)’) If the proposal is too sensitive to be financed because you do not have the appropriate experience, skills or permissions to guarantee security of the information, we will refuse funding. If we refuse funding, will inform your coordinator (via a ‘proposal rejection letter’ sent through the electronic exchange system), together with the reasons why and how to appeal. If the reasons for rejection are themselves ‘EU classified’, we cannot include them in the rejection letter. 3 See Section 27 of Commission Decision 2001/844/EC, ECSC, Euratom. Available at http://eur-lex.europa.eu/legal- content/EN/TXT/PDF/?uri=CELEX:32006D0548&from=EN. 22
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